The Context-Aware Pill Bottle and Medication Monitor Video – Great Without Glitz

There is nothing technologically unique about the Context-Aware Pill Bottle and Medication Monitor (an accurate but not euphonious and decidedly not catchy name) from the University of Calgary, and there is certainly nothing slick in the production values of the video about that appliance. Yet, it is indeed a must-see presentation.

The first portion of the video, which explains the intent, positive effects, and workings of the mechanism, will appear familiar to anyone who has seen promotions for medication dispensers/reminders, but the portion that follows the “Critique” heading enters uncharted territory to those who don’t routinely attend research meetings. It is during this critique, you see, that the same individual who presented all the benefits of the device discusses possible flaws in its design. The informative critique is not only enlightening but also heartening.

Of course, this is a video version of a research paper. One shouldn’t expect an ad agency to suggest the same sort of balanced presentation to a client trying to sell a product.

Abstract: The video illustrates and critiques a context-aware pill bottle/stand that reminds the elderly when it is time to take their medication. A medication monitor situated in a caregiver’s home displays awareness information about the elderly user’s medication compliance.

Half Of US Pregnancies Unintended

An article in the Health Journal portion of the 20 April 2010 Wall Street Journal, The Birth-Control Riddle by Melinda Beck, offers these impressive statistics regarding unintended pregnancies:

Almost half of all pregnancies in the U.S.—some 3.1 million a year—are unintended, according to the most recent government survey, from 2001. ((The same article goes on to note: “An updated version of those numbers from the 2006 National Survey of Family Growth is expected to be released next month. But population experts don’t anticipate much change; the rate of unplanned pregnancy was the same in 1994, and smaller studies have found that even newer birth control methods haven’t made much of a dent.”)) One out of every two American women aged 15 to 44 has at least one unplanned pregnancy in her lifetime. Among unmarried women in their 20s, seven out of 10 pregnancies are unplanned.

While the causes of the problem may be, as the article’s title indicates, a riddle, its mechanics are not:

Almost half (48%) of unintended pregnancies involve contraceptive failures. In 52% of cases, couples used no birth control at all. Cost is a factor for some of them. Even though most insurers now cover contraceptives, co-pays and deductibles can still present obstacles.

And many young people are in “the fog zone” in which their beliefs about pregnancy don’t match their behaviors, according to a 2009 report by the National Campaign to End Teen and Unplanned Pregnancy. In a survey conducted by the Guttmacher Institute of 1,800 single men and women aged 18 to 29, more than 80% of both sexes said it was important to them to avoid pregnancy right now, yet 43% of those who are sexually active said they used no contraception or used it inconsistently.

The following chart from the CDC (not in the WSJ article) offers confirmation of the premise that most couple incidents of unintended pregnancy were the result of not using any contraceptives.

In 2002, among women who reported that their pregnancy was unintended, the prevalence of contraceptive (any method) use at the time of pregnancy ranged from 38.7% (Hawaii) to 53.3% (Vermont).

During 2000–2002, the prevalence of contraceptive (any method) use at the time of pregnancy among women with an unintended pregnancy decreased in 4 states (Florida, New Mexico, New York, and North Carolina).

Education And Technology As Solutions

Some population experts say the rates of unintended pregnancy would be far lower if more women used IUDs and implants that prevent pregnancy for years at a time. Only about 3% of American women currently do.

“There are terrible misperceptions about these methods— and about all forms of contraception,” says James Trussell, director of the Office of Population Research at Princeton University.

Many traditional forms of contraception have been updated in recent years. Here’s a look at the latest developments: …

A summary of the pros and cons of various contraceptive methodologies, under the headings, The New IUDs, The Implant , Hormone Pills, Patches And Rings,Condoms, Caps And Sponges, Emergency Contraception, Permanent Birth Control, and Vasectomy Variations, completes the piece.

The Problem With Education And Technology As Solutions To Noncompliance

The advancements in effectiveness, safety, and ease of use of contraceptive technology are important and may well trigger incremental improvements in the rate of use of these methods. Nonetheless, the emphasis on improved technology begs the question of why none of the previously available, well publicized contraceptive methods (e.g., birth control pills, abstinence, diaphragms) were used in half of all unintended pregnancies.

And, educating patients beyond the basics (i.e., the instructions for safe and effective treatment implementation and a simple explanation of how the medication, diet, surgical procedure, etc. works) has rarely proved successful in significantly ameliorating noncompliance.

The most problematic aspect of the focus on education and technology, however, is that it distracts from other possible factors, including the cultural, socioeconomic, and psychological issues that may prevent a woman and her partner from using any contraceptive method regardless of their understanding or appreciation of the technology.

Given that unintended pregnancy has been shown to influence a woman’s behavior and experiences during pregnancy and in the post-natal period to the detriment of the health of her infant, this is a noncompliance problem that merits a more inclusive response than appeals for more education and tbetter technology, however worthy those efforts may themselves be.

Development of an effective methodology for managing patient noncompliance remains unlikely as long as the strategies being investigated are limited to those already shown to be ineffective.
Key Point: Noncompliance is not exclusively a medical issue but a personality trait that manifests in many areas of life. Treating patient compliance as though it’s a straightforward, sui generis phenomenon independent of other human behavior all but eliminates the potential for significant advances in the field.

Employing a Copernican perspective to find compliance solutions that work

Do away with the restrictions implicit in the contention that healthcare compliance is unique.

Change the compliance game from clinician vs. patient to clinician & patient vs. problem being treated

Rethinking Patient Noncompliance – Again

Once more unto the breach, dear friends, once more ((“King Henry V” by William Shakespeare: Act 3. Scene I))

Paul Tunnah, founder of pharmaphorum, an online pharma discussion and networking site, invited me to submit an overview of patient noncompliance. The first portion of that paper was published today at Rethinking patient noncompliance (Part 1).

While those who have followed my efforts on AlignMap will find little that is surprising, the article does, I think, offer a coherent, condensed summary of the current, problematic status of treatment adherence. The main points, sans discussion, follow:

The Dysfunctional Concept Of Patient Compliance

1. Patient compliance, as described by its standard definition, is a useful statistical measure but an inadequate and often counterproductive explanatory concept. Key Point: The term patient noncompliance, by definition, is no more than a descriptive label given to a phenomenon and indicates nothing about the cause of that phenomenon.

2. Noncompliance leads to inadequate implementation of treatment recommendations, which itself leads to devastating economic and personal consequences.Key Point: Characterizing the financial, physiological, and social costs of patient noncompliance as catastrophic is neither hyperbole nor hysteria, just fact.

3. Patient noncompliance is, by any measure and from any perspective, pervasive and difficult to detect.Key Point: While patient compliance varies, a reasonable expectation, absent evidence to the contrary, is an average compliance rate of 50%.

4. No practical methodology has been shown to significantly, reliably, and enduringly enhances compliance for a diverse patient population.Key Point: Many methodologies designed to enhance compliance are effective – for some patients some of the time; none of these methodologies are effective for most patients most of the time. Further, no methodologies have been demonstrated to predict which patients will and will not follow treatment recommendations or which patients will respond to which compliance enhancement techniques.

Solutions, AKA Coming Attractions

A new perspective on treatment adherence that offers potential solutions is the focus of Part 2 of Rethinking Patient Noncompliance, which will be published at pharmaphorum next week.

I must admit that my immediate, automatic reaction to theHealthPrize Technologies site was a flinch. Like most healthcare professionals, I am unaccustomed to seeing treatment adherence linked to winning prizes.

It’s all based on the simple idea that people respond to two things: money and fun. So we’ve developed a system that links adherence-tracking technologies to a series of financial incentives, like points, prizes, and cash. And the better consumers are about taking their medication, the more chances they have to win and the more fun they’ll have.

Differing opinions about the appropriateness of offering incentives for compliance with healthcare regimens is hardly a new topic. A partial list of AlignMap posts on this issue includes

The contentiousness triggered by this methodology has more to do with cultural, philosophical, and ethical concerns than pragmatic results. There is an impressive amount of evidence that supports the notion that fiscally based incentives (e.g., cash, coupons, and merchandise) can increase rates of treatment adherence.

Currently, an odd dichotomy of opinions on the matter exists. There is relatively little criticism heard, for example, about corporate wellness programs offering prizes and other incentives to obese participants who lose weight or to tobacco-using participants who are able to stop smoking. Offering those same prizes or similar incentives, however, to participants for following a prescribed medication regimen or undergoing indicated medical screenings is likely to result in charges of unethical behavior, mind control, and disreputable motives.

Given that some bioethicists insist that only an absolutely neutral presentation of treatment options to patients is acceptable, the idea of offering prizes for executing a course of treatment is sure to result in controversy.

For my part, incentives seem one more tactic that has been shown to enhance treatment adherence in some patients. In that sense, it falls in the same category as reminders, the use of pill boxes or automated medication dispensers, regimen simplification, adding a second medication to ameliorate the primary drug’s side, educating the patient about the workings of the medication, …

The key ethical issue would seem to be distinguishing the use of incentives to drive the behaviors necessary to execute a prescribed treatment from the use of incentives to drive the mindless ingestion of one pill or another.

It’s important because incentives have been shown to be effective for a significant number of patients (albeit not all)

It’s important because, as I have pointed out on occasion, 2 repeating the same processes tends to produce the same results. In the case of patient compliance, that means trying the same adherence enhancement that didn’t work the first 821 times probably won’t work the 822nd time. Trying something new (not just another version of the same tired idea), is essential; trying something that has only been used on a limited scale, such as incentives, is astutely logical.

Finally, it’s important because we need to be looking for methodologies that enhance compliance by enhancing the alliance of the patient with those involved in his or her healthcare, including clinicians, Pharma, third party payers, and other stakeholders. Fun would be a potent force to effect that alignment.

I cannot predict how effective this particular take on using incentives to improve treatment adherence will be clinically, and I certainly have no idea if HealthPrize Technologies will prove a commercial success. It does seem, however, that adding a potentially useful, currently unavailable weapon to combat certain kinds of unintentional noncompliance to our clinical armamentarium could be – well, fun.

Adherence Enhancement – Fun vs Futility

The perspicacious identification of AlignMap as the “ultimate in compliance resources”

The equally perspicacious and arguably more significant observation that “… the reason we haven’t made an impact is because we test and use one intervention at a time. … What we need to offer is a wide choice of different compliance programs with each individual enrolled in the programs that are going to impact them.”

The proposition that fun might well be a motivator for adherence behaviors

Why Fun Is Important In Transforming Compliance

The argument made for fun is convincing and – well, fun.

It’s also important.

It’s important because the Adherence Can Be Fun hypothesis looks like it might work. ((Admittedly, I have no credentials as an expert on fun; still, …)) Rather than repeat the argument Jonathon Richmond makes, I suggest you read his post and see for yourself. I think you’ll be impressed.

Finally, it’s important because we need to be looking for methodologies that enhance compliance by enhancing the alliance of the patient with those involved in his or her healthcare, including clinicians, Pharma, third party payers, and other stakeholders. Fun would be a potent force to effect that alignment.

Don’t say “Adherence” when you mean “Brand Loyalty”

“Compliance,” ((In this post, “Compliance” and “Adherence” are used interchangeably)) if it is to have useful significance as a term, cannot be used as code for “selling more medication X.” ((I hasten to add that I have no problem with the notion of selling more medication X. It’s one of my favorite pharmaceutical agents, useful for any number of ailments and almost devoid of side-effects. I object only to its marketing being confused with medication compliance.))

A helpful rule of thumb follows:

If an alleged Medication Compliance Program applies to only one drug or one small group of drugs, all produced by the same manufacturer, what you’ve got yourself there is not a Medication Compliance Program but a Brand Loyalty Program.

A Medication Compliance Program is concerned with all the medications in a patient’s regimen; eliminating or replacing a given medications from a patient’s regimen does not disqualify a patient from participation in a Medication Compliance Program. ((The exception, of course, is a single-agent Medication Compliance Program that concerns treatment deemed so essential that its proper execution warrants special adherence protocols (e.g., DOT in the case of tuberculosis treatment). One supposes that a Medication Compliance Program could also legitimately focus on a single given medication with inherent qualities, such as a particularly complex dosing schedule or overwhelmingly noxious side-effects, that rendered adherence especially difficult. I have, however, yet to find a Medication Compliance Program for a single drug that described its intent in that manner or its drug of focus in those terms))

Again, I am enough of a believer in free market theory that I don’t seek to ban Brand Loyalty Programs for pharmaceuticals as long as the programs do not promote the inappropriate prescription or continuation of the medications on which they focus – and the intent of the Program (i.e., to sell more doses of Medication X) is made transparent to doctors and patients.

That one can certainly devise a lexicographical rationale for using “compliance,” “adherence,” and similar terms in association with Brand Loyalty Programs does not mitigate the ongoing confusion about the concept of compliance.

The How To Fix Patient Compliance Now Series

This is the third in a series of posts offering steps to improve the study of and communication about patient compliance. These recommendations are simple and inexpensive; their implementation, in fact, is solely a function of motivation on the part of those working in the field. Finally, the benefits of these recommendations are magnificently self-apparent.

Step #3. Support compliance claims

AKA Back it up or shut it up
AKA Don’t claim it if you can’t name it

Claims that, for example, medication compliance will be or has been improved by a new drug or the use of an automated reminder service has achieved X% adherence rate for participation in a disease screening program exam, must be accompanied by evidence.

Not doing so could mislead a naive audience; even worse, claims made without evidence to a more knowledgeable (or more cynical) audience may well play a role in making the entire field dealing with treatment adherence suspect. After all, if retailers of compliance enhancements, developers of a specific compliance model, and adherence promotions run by third party payers, pharmaceutical manufacturers, and independent firms boast of compliance rates so high they would mark a major breakthrough in the field but provide no support or only allude to vaguely defined “studies” that, if existent, can’t be found, readers and viewers will (and should) be suspicious of compliance claims in general.

An Example From Real Life

When a medication adherence program administered under the imprimatur of a major health insurer claims a 95% compliance rate for treatments that typically carry a significantly lower rate of adherence, their press releases, especially those directed to clinicians, are, I contend, obligated to show the evidence. Was there a blind study with a control group? How was the rate calculated? If there was a study, was it run by an independent party or was it done internally? Without that basic information, the claim of a 95% compliance rate is little more than puffery.

That my repeated emails to the program director asking for this information receive no response is, unfortunately, all too typical and tends to abet my suspicions that something is being hidden.

Proprietary Is Not A Magic Word

I’ve been involved in enough business matters to understand the value of trade secrets and necessity of not revealing proprietary information.

On the other hand, I also know the difference between abracadabra and proprietary. And, I know there is something fundamentally wrong about declaring that the substance of a proprietary study must be kept secret while simultaneously claiming the alleged findings from that same study as evidence that a given compliance intervention or program is successful.